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Completed

NCT Number: NCT02625311

Comparing Minimal Invasive Surgery en Conventional Total Knee Arthroplasty

Randomized clinical trial comparing minimal invasive operating technique to conventional operating technique for placement of total knee prosthesis.

Clinical evaluations, patient questionnaires, X-rays and CT scans were done to compare these two techniques.

Completed

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Key information

Conditions

Osteoarthritis, Knee Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases

Age range

45 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

Study executed with 3 centers and 69 patients.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patient requiring Total Knee Arthroplasty (TKA)
  • patients with Osteo arthritis
  • intact collateral ligaments and patella tendon
  • patients willing and able to comply with the post-operative schedule

Exclusion criteria

  • patients who require a revision TKA
  • patients with TKA contralateral knee within 6 months with bad outcomes
  • patients who need a TKA on contralateral side within 2 years
  • intraoperative resurfacing of patella
  • intraoperative eversion of patella
  • patients who had prior procedure of involved knee such as high tibial osteotomy, cruciate ligament recontruction, knee fusion or patellectomy
  • BMI > 30
  • patients with fixed flexion contracture> 15 degrees
  • patients with deformity greater than 20 degrees of varus or 15 degrees of valgus
  • Patient with Mediolateral stability > 10 degrees patient with active or suspected malignancy
  • patient with Rheumatoid arthritis
  • patient with systemic disease that would effect subject's wellfare or overall outcome of the study
  • patient with other severe concurrent joint involvement which can effect their outcome
  • patients with an immobile hip
  • patient with a history of Pulmonary embolism or Deep venous thrombosis

Treatment and study plan

surgery method using CR TKP

Procedure

Operation through minimal invasive surgery or standard open surgery

Other names: Cruciate retaining (CR total knee prosthesis (TKP) Stryker

Primary outcomes

  1. range of motion

    Time frame: pre-op vs post-op until 5 years post-op

    measurement of flexion and extension in degrees

  2. blood loss

    Time frame: 24 hours after surgery

    measurement of milliliters blood loss during the first 24 hours after surgery

Secondary outcomes

  1. patient questionnaire

    Time frame: pre-op vs post-op until 5 year post operative

    WOMAC pain and function score

  2. chair rise and stair climb test

    Time frame: pre-op vs post-op until 5 years post operative

    Ability of patient rise from chair and climb stairs, amount of pain on VAS 1-10 does the patient have during these activities

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Registry information

Official study title

A Prospective Comparative Randomized International Multicenter Study Comparing MIS Computer Navigated Total Knee Arthroplasty vs Conventional Computer Navigated Total Knee Arthroplasty

Acronym: MIS

Important dates

Study start
2004
Primary completion
2011
Study completion
2015
First posted
Dec 9, 2015
Registry last updated
Dec 9, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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